UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II clinical trial for aGalCer resembling medicine,OCH in patients with Crohn s disease
Title of the study (Brief title)	OCH NCNP1
Region	Japan

Condition
Condition	Crohn disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The safety of tolerability of OCH is evaluated in patients with Crohn s disease
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Adverse event
Key secondary outcomes	Clinical efficacy Pharmacokinetics of OCH Pharmacodynamics of OCH

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Cohort A (0.3mg daily) 4 cases
Interventions/Control_2	Cohort B (3mg daily) 4 cases
Interventions/Control_3	Cohort C (6mg daily) 4 cases
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) The patient who has been diagnosed as Crohn s disease 2) Patients whose CDAI is 150-450 others criteria can not uploaded due to the space.
Key exclusion criteria	1) The patient who is suspected as other inflammatory bowel disease except Crohn s disease 2) Patient who will need bowel resection within 12 weeks after the entry of clinical trial. 3) Patient who is entering to another clinical trial or who receive medical treatment in any other clinical trial within 12 weeks prior to entry of the present clinical trial. others criteria can not uploaded due to the space.
Target sample size	12

Research contact person
Name of lead principal investigator	Takanori Kanai and Makoto Naganuma
Organization	School of Medicine, Keio University
Division name	Department of Internal Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL	03-3353-1211
Email	nagamakoto@z7.keio.jp

Public contact
Name of contact person	Yoko Ito
Organization	Keio University Hospital
Division name	Planning and Management Office Clinical and Translational Research Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL	03-5315-4278
Homepage URL
Email	pmo@ccr.med.keio.ac.jp

Sponsor
Institute	School of Medicine, Keio University Department of Internal Medicine
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 08 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 05 Month 10 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 06 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027096